Treatment of serious COVID-19 infection by combining suppression of testosterone and using a high dose of estrogens

/in ,

Pantarhei Oncology announces the publication of its scientific paper “Testosterone suppression combined with high-dose estrogen as potential treatment of serious COVID-19 infection” (Heliyon 8 (2022) e12376)

COVID-19 infections are more serious and have a higher mortality in males compared to females especially at ages above 50 years. This is related to the 10-20x higher testosterone (T) levels in males. Suppression of T in males with serious COVID-19 has no consistent effect on the clinical outcome. However, by suppressing T in males, also their estrogen levels are decreased while estrogens have a favorable inhibitory effect on the factors responsible for the COVID-19 infection. Therefore, we hypothesize that a combination of T suppression by androgen-deprivation therapy (ADT) and high-dose estrogen (HDE) treatment may be an effective treatment of serious COVID-19, to be confirmed in in seriously ill COVID-19 patients.

The scientific background of this hypothesis

Most studies report a higher incidence of serious COVID-19 infections in males compared to females especially at ages above 50 years, which may be due to sex-related immunomodulation. A resulting higher mortality rate has been published in Maturitas, both in a meta-analysis performed in May 2020 and in a recent retrospective analysis. These observations could be associated with the 10-20x higher testosterone level in males, since testosterone has unfavourable effects on the immune system, and also stimulates angiotensin converting enzyme-2 (ACE2) and the androgen-regulated protease transmembrane protease serine 2 (TMPRSS2), which both facilitate the entry of the COVID-19 virus into the cell. Testosterone suppression by ADT decreases the effects of ACE2 and TMPRSS2. Estrogen treatment (ET) has the same beneficial suppressive effect on ACE2 and TMPRSS2 as ADT. Both ADT and ET (ADET) have been investigated separately as possible treatments of SARS-CoV-2. We hypothesize that the ADET combination may be more effective than its components alone, as also suggested in our Research Letter in European Urology (2021), entitled ‘Treatment of Serious COVID-19 with Testosterone Suppression and High-dose Estrogen (HDE) Therapy‘. The ADET co-treatment has been investigated successfully by Pantarhei Oncology in patients with advanced prostate cancer (Eur Urol Open Science, 2021 & 2022). We searched the literature for evidence of COVID-19 treatment benefits with estrogens, progesterone, androgen deprivation, and anti-androgens. Data supporting the effect of ADT on SARS-CoV-2 are sparse, but the favorable effects of estrogens in relation to COVID-19 have been shown in various cohort studies.

Based on the outcome of our review and the mode of action of the ADET combination, we hypothesize that a combination of ADT and HDE may be an effective and safe treatment of serious SARS-CoV-2 and we propose to test this ADET hypothesis in a clinical trial.

 

 

“Maintaining bone health by estrogen therapy in patients with advanced prostate cancer: a narrative review”

/in ,

Pantarhei Oncology proudly announces that its paper “Maintaining bone health by estrogen therapy in patients with advanced prostate cancer: a narrative review” has been published in the journal Endocrine Connections after comprehensive review. This journal is an international peer-reviewed, scientific, open access journal in the field of endocrinology.

In this paper we review the new and safer estrogen therapies, including high dose estetrol (HDE4), to maintain bone mass and prevent fractures in advanced prostate cancer patients treated with androgen deprivation therapy (ADT).

 

Estetrol Prevents Hot Flushes and Improves Quality of Life in Patients with Advanced Prostate Cancer Treated with Androgen Deprivation Therapy: The PCombi Study

/in ,

Pantarhei Oncology proudly announces that its paper ‘Estetrol Prevents Hot Flushes and Improves Quality of Life in Patients with Advanced Prostate Cancer Treated with Androgen Deprivation Therapy: The PCombi Study’ has been published in the journal European Urology Open Science after comprehensive review. This journal is an international peer-reviewed, scientific, open access journal in the field of urology.

This paper summarises the very important data on the beneficial effects of high dose estetrol (HDE4) on the Quality of Life of prostate cancer patients treated with androgen deprivation therapy (ADT).

 

 

 

 

European Urology Today, the official newsletter of the European Association of Urology, publishes the results of the PCombi study

/in

European Urology Today, the official newsletter of the European Association of Urology, publishes the results of the PCombi study

Pantarhei Oncology has developed a new concept for the endocrine treatment of locally infiltrating and/or metastatic prostate cancer in collaboration with two renowned Dutch urologists, Prof. Frans Debruyne, formerly at the Radboud UMC, Nijmegen and Prof. Jeroen van Moorselaar, Free University, Amsterdam. This collaboration has resulted in the performance of the prospective, randomized, double-blind, placebo-controlled PCombi study in four Dutch urology centers by Dr. Erik Roos (Sneek), Dr. Rik Somford (Nijmegen), Dr. Ton Roeleveld (Alkmaar) and Dr. Tjard de Haan (Zwolle) in men with advanced prostate cancer, who started androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist to suppress testosterone levels. Major side effects of ADT are loss of libido and sexual function, but since the loss of testosterone also implies the loss of testosterone derived estrogens, especially estradiol (E2), most side effects of ADT are related to estrogen deficiency. These side effects are the same as the symptoms of estrogen deficiency occurring in postmenopausal women and include hot flushes and sweatings, joint pain (arthralgia), sleep disturbances, mood changes and depression, fatigue, loss of energy, muscle weakness (sarcopenia), cognition problems, bone loss and an increased fracture risk with, especially in aging males, a higher risk of mortality.

The results of the Phase II PCombi study were recently published in the European Urology Open Science.  The study has demonstrated several significant estrogen supplmentation and biochemical anti-tumor effects. Patients treated with E4 had fewer symptoms of estrogen deficiency than patients treated with placebo. The high dose E4 treatment was well-tolerated with no treatment-related cardiovascular adverse events.

European Urology Today, the official newsletter of the European Association of Urology, now reports on this publication: European Urology Today Vol. 33 No.5 – October 2021/ January 2022 by European Association of Urology (EAU) – Issue.

 

 

19th Association of Academic European Urologists Meeting (AAEU), December 2-5, 2021, Marseille (France)

/in

19th Association of Academic European Urologists Meeting (AAEU), December 2-5, 2021, Marseille (France)

On 5th of December 2021, Prof. Jeroen van Moorselaar of the Amsterdam University Medical Centre in the Netherlands, lectured during the annual meeting of the AAEU in Marseille on the results of the PCombi study sponsored by Pantarhei Oncology. The title of his lecture: Estetrol improves quality of life in advanced castration-sensitive prostate cancer: a randomized clinical trial.

According to Prof. Van Moorselaar, the results were well received. He got a lot of enthusiastic reactions from the audience. He will give the same presentation at the International Prostate Cancer Update (IPCU) in Utah (US) beginning of March 2022.

 

 

Pantarhei Oncology receives positive advice from the FDA to initiate Phase III development of estetrol for prostate cancer treatment

/in

Pantarhei Oncology receives positive advice from the FDA to initiate Phase III development of estetrol for prostate cancer treatment

After having achieved proof-of-concept in human for estetrol (E4) as a potential combination treatment with androgen deprivation therapy (ADT) of advanced prostate cancer, Pantarhei submitted a Pre-Investigational New Drug Application (Pre-IND) to the US Food & Drug Administration (FDA) for guidance on the further development with this new combination treatment.

In a positive meeting with the FDA, the company has reached an agreement on their development plans including a proposal for a Phase III clinical study. Based on this outcome, the PCombi project (E4 for prostate cancer patients) is now ready to start Phase III, the final stage of development to bring the product to the market.

The next study will be a pivotal phase III, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of estetrol as co-treatment with ADT in patients with advanced prostate cancer. Main objectives are to evaluate E4 treatment for the prevention of estrogen deficiency symptoms caused by the ADT (such as hot flushes and bone loss) and for its additional anti-tumor effects.

The company is currently looking for a strategical or financial partner for further financing the development of this project.

 

Interview met Herjan Coelingh Bennink en Iman Schultz in BiotechNEWS & Life Sciences

/in

Estetrol voldoet aan hooggespannen verwachtingen.

Goedkeuring voor het gebruik van het unieke natuurlijke zwangerschapsoestrogeen estetrol (E4) in een anticonceptiepil. Canada was recent de eerste, EMA en FDA volgden. Het zijn mijlpalen in het bestaan van Pantarhei Bioscience die het oestrogeen ontwikkelde. Maar het E4 toepassingsgebied is veel breder: binnen Pantarhei Oncology wordt het nu ook ingezet bij de behandeling van gevorderde borst- en prostaatkanker. Het ‘brein’ achter E4, gynaecoloog en reproductief endocrinoloog em. Prof. Dr. Herjan J.T. Coelingh Bennink (President en Founder) en Dr. Iman Schultz, Director R&D, vertellen.

Lees hier het interview met  met Herjan Coelingh Bennink en Iman Schultz in BiotechNEWS & Life Sciences.

 

 

 

European Commission approves new oral contraceptive containing E4

/in

European Commission approves new oral contraceptive containing E4
Dutch pill previously approved in the USA and Canada

Zeist, the Netherlands, 21 May 2021 – Pantarhei Bioscience announced today that the European Commission has approved the new oral contraceptive Estelle®. This contraceptive pill contains Estetrol (E4), an estrogen developed by Pantarhei Bioscience since 2000. At the end of March, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) already gave a positive opinion for Estelle®.

For more information, please read the Press Release.

 

Goedkeuring Europese Commissie voor anticonceptiepil met E4
Nederlandse pil eerder al goedgekeurd in de VS en Canada

Zeist, 21 mei 2021 – Pantarhei Bioscience maakt bekend dat de Europese Commissie goedkeuring heeft gegeven voor de nieuwe anticonceptiepil Estelle® met daarin het door Pantarhei Bioscience ontwikkelde oestrogeen Estetrol (E4). Eind maart had het adviescomité (CHMP) van het Europees Geneesmiddelenagentschap (EMA) reeds een positieve opinie gegeven voor deze pil.

Voor meer informatie lees hier het Nederlandstalig Persbericht.

 

 

 

 

Pantarhei Oncology reports breakthrough in prostate cancer treatment

/in

Pantarhei Oncology reports breakthrough in prostate cancer treatment

Zeist, 11 May 2021 – The leading scientific journal European Urology Open Science (EUROS) has reported the results of a new treatment of advanced prostate cancer developed by Pantarhei Oncology, a biotech company located in Zeist, the Netherlands. Pantarhei Oncology has demonstrated, that by combining the standard of care androgen deprivation therapy (ADT) with the natural estrogen Estetrol (E4), side effects of ADT are significantly reduced and additional long term anti-tumor effects are expected.

For more information, please read the Press Release or the article

 

Pantarhei Oncology rapporteert doorbraak in prostaatkanker behandeling  

Zeist, 11 mei 2021 – Het toonaangevende wetenschappelijke tijdschrift European Urology Open Science (EUROS) heeft de resultaten van een door Pantarhei Oncology ontwikkeld nieuw geneesmiddel voor de behandeling van patiënten met gevorderde prostaatkanker gepubliceerd. De combinatie van de standaard hormoon therapie, bekend als ADT, met het natuurlijke oestrogeen Estetrol (E4), vertoont aanzienlijk minder bijwerkingen en heeft sterkere anti-tumor effecten.

Voor meer informatie lees hier het Nederlandstalig Persbericht  of het artikel

 

 

 

Positive results of E4 co-treatment with androgen deprivation therapy for advanced prostate cancer has been published in European Urology Open Science

/in ,

Positive results of E4 co-treatment with androgen deprivation therapy for advanced prostate cancer has been published in European Urology Open Science

Pantarhei Oncology proudly announces that its paper ‘Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi)’ has been published in the journal European Urology Open Science after comprehensive review. This journal is an international peer-reviewed, scientific, open access journal in the field of urology.

The research paper reports the results of the PCombi study, a phase II, double-blind, randomised, placebo-controlled, multi-centre study in males recently diagnosed with locally advanced or metastatic prostate cancer, who started ADT treatment with an LHRH agonist. The ADT-treated patients were co-treated for 24-weeks with 40 mg E4 or placebo. The high dose E4 treatment was well-tolerated and no treatment-related cardiovascular adverse events were observed. Patient treated with E4 reported fewer complaints of estrogen deficiency symptoms and better quality of life than patients who received placebo. With E4, 6% of the patients reported hot flushes compared to 55% of patients treated with placebo. Total and free testosterone, prostate-specific antigen (PSA), and follicle-stimulating hormone (FSH) were suppressed more rapid and profound, suggesting enhanced disease control by E4. In addition, bone turnover was substantially reduced in the E4-treated patient implicating a bone-sparing effect. The study results have now been published in European Urology Open Science (EUROS).

 

IMPRINT

Pantarhei Bioscience BV | Boulevard 17 | 3707 BK Zeist | The Netherlands
Phone: +31 (0)30 6 985 020 | Email: info@pantarheibio.com

DISCLAIMER

The information contained in this website is for general information purposes only. The information is provided by Pantarhei Bioscience and while we endeavour to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

SOCIAL MEDIA

Pantarhei Bioscience | Privacy | Disclaimer

© 2023